Orthopedic Surgery Clinical Trial
— PROBRAINOfficial title:
Brain Power Spectral Density Under Propofol and Its Association With Cerebral Fragility, an Objective Means to Estimate the Probability of Presenting Burst Suppression
Verified date | March 2019 |
Source | Hopital Lariboisière |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
In the operating room, the state of anesthesia is monitored during general anesthesia-induced hypnosis through EEG-based neuro-monitoring. Recent studies suggest that variables extracted from per-operative EEG change as brain ages. Furthermore, aging is itself an independant factor associated to an increased sensitivity to General Anesthesia (GA). Among fragility sign, per-operative Burst Suppression (BS) has been associated to a poor postoperative cognitive trajectory. The main goal of this observational clinical study is to extend the traditional use of per-operative EEG to the detection and prediction of various degrees of brain fragility, depending on the depth of anesthesia (DoA).
Status | Completed |
Enrollment | 60 |
Est. completion date | January 5, 2016 |
Est. primary completion date | January 5, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients > 18 years scheduled an elective interventional neuroradiology procedure or orthopedic surgery performed under general anesthesia. - oral agreement obtained from each patient before anesthesia Exclusion Criteria: - age <18 years - an emergency procedure |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Joaquim MATEO | INSERM UMR-942, Paris, France, LMS Polytechnique and M3DISIM, Inria, Université Paris-Saclay |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Values of Patient State Index (PSI-) are collected from frontal electrodes montage (Fp1, Fp2, F7, F8) | For all patients values of Patient State Index (PSI -) will be collected during Total Anesthesia Period (induction and hypnotic periods) | Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)]] | |
Primary | Propofol doses administered with Target Controlled Infusion (TCI in µg/ml) | For all patients values of Target Controlled Infusion (TCI in µg/ml ) will be collected during Total Anesthesia Period (induction and hypnotic periods) | Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)]] | |
Primary | Values of Burst Suppression (in % of time) are collected from frontal electrodes montage (Fp1, Fp2, F7, F8) | For all patients values of Burst Suppression (in % of time) will be collected during Total Anesthesia Period (induction and hypnotic periods) | Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)]] | |
Primary | Values of the Spectral Edge Frequency (SEF 95 in uV2/Hz) are collected from frontal electrodes montage (Fp1, Fp2, F7, F8) | For all patients values of the Spectral Edge Frequency (SEF 95 in uV2/Hz) will be collected during Total Anesthesia Period (induction and hypnotic periods) | Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)]] |
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